Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, Drug Product Manufacturing is an experienced operations leader responsible for CMC development and GMP manufacturing of Ultragenyx’s drug product formulations, including small molecule and oligonucleotide products. This role leads external drug product manufacturing activities, supports reliable clinical and commercial supply, and contributes to strategic planning within Technical Operations. The position serves as a recognized technical expert and partners cross‑functionally across Quality, Regulatory, Supply Chain, and Development organizations. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Lead external drug product manufacturing for small molecule and oligonucleotide products in a cGMP environment. 
2. Oversee production planning, execution, and performance tracking to ensure clinical and commercial supply commitments are met. 
3. Manage CMO relationships, including selection, onboarding, and performance management, fostering strong collaborative partnerships. 
4. Lead or support CMC activities across the drug product portfolio, including authoring and reviewing CMC sections for global regulatory filings (INDs, IMPDs, NDAs, MAAs). 
5. Serve as an integral member of cross‑functional CMC teams, partnering with Quality, Regulatory, Supply Chain, Development, and Clinical teams. 
6. Develop and maintain manufacturing documentation, including Product Design History Files and Quality Risk Management Plans. 
7. Oversee process development, technology transfer, process optimization, and lifecycle management activities. 
8. Manage manufacturing-related deviations, change controls, investigations, and complaint responses. 
9. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing governance documents. 
10. Promote knowledge management, documentation best practices, continuous improvement, and operational excellence initiatives while representing Drug Product Manufacturing on global and cross‑functional teams. 

Requirements:

1. PhD or equivalent relevant experience in Pharmaceutical Sciences, Engineering, or related discipline. 
2. 10–15+ years of experience in pharmaceutical or biopharmaceutical manufacturing, preferably within global organizations. 
3. Demonstrated expertise in small molecule drug product development and clinical/commercial manufacturing; experience with multiple dosage forms preferred. 
4. Strong knowledge of QbD, DoE, process validation/qualification, phase‑appropriate manufacturing controls, PAT, and current regulatory expectations for drug products. 
5. Working knowledge of cGMP, ICH guidelines, and global regulatory submission requirements. 
6. Proven track record managing and sustaining effective CMO partnerships in a matrixed organization. 
7. Experience with analytical development and quality control is a plus. 
8. Strong problem‑solving, leadership, communication, and financial acumen. 
9. Commitment to coaching, feedback, and continuous learning and development.  

Physical Demand Requirements   

Office‑based role with occasional presence in manufacturing and partner facilities. requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body may be required during site visits or when attending as person-in-plant. This requires the ability to change clothes into appropriate gowning and personal protective equipment.  

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Position Summary:

The Inventory & Cost Accounting Manager, will report to the Senior Director, Revenue and Cost Accounting and play a key role in supporting inventory & cost accounting, as well as assisting with other accounting activities. This role will also be working closely with cross-functional teams throughout the company.

Responsibilities:

Inventory & Cost Accounting:

• Develop a strong business partner relationship with the Supply Chain Manufacturing, Quality, and Process Development functions.
• Prepare and manage cost accounting month-end close journal entries for prepaid manufacturing costs, raw materials, work-in-process and finished goods inventories, and cost of sales while maintaining subledger accounts, reconciliations to ensure compliance with U.S. GAAP.
• Own Inventory and COGS analytics and reporting, including development and maintenance of margin and variance analyses to support business decision-making.
• Support other month end close journal entries and reconciliations as opportunities arise.

Inventory Management & Controls:

• Work directly with contract manufacturing, supply chain, quality, internal & external audit to ensure accurate inventory, existence, valuation, and reporting completeness.
• Assist with SOX efforts in documenting and performing key controls in areas of responsibility.

Systems & Process Improvements:

• Represent inventory & cost accounting related to ERP and system enhancements and process improvements to strengthen data accuracy, automation, and internal controls.
• Continuously evaluate processes and recommend improvements to enhance efficiency and effectiveness.
• Maintain up to date accounting policies and desk procedures to drive operational efficiency.
• Assist with annual audits and quarterly reviews, preparing audit schedules, and other audit requests.
• Maintain a thorough and current understanding of general ledger structure and ensure integrity and accuracy of financial data.
• Potentially provide support for other functions such as revenue accounting, special projects, initiatives, and ad-hoc analyses, as needed.

Qualifications:

• Bachelor’s degree in accounting, finance, or related field.
• 5+ years of relevant experience in biotech and/or pharmaceutical industry.
• Strong working knowledge of system processes, internal controls, GAAP and SOX regulations.
• Strong project management skills with the ability to anticipate events, prioritize assignments, deal with interruptions, and meet deadlines in a fast-paced and growth-oriented environment.
• Strong communication, project management, and organizational skills.
• Strong analytical skills and attention to detail.
• Ability to work independently as well as a collaborative team player.
• Self-starter, proactive, and willing to learn.
• Strong Excel skills.
• Experience working as a contract manufacturing sponsor with inventory & cost accounting in the pharmaceutical industry, a plus.
• Certified Public Accountant (CPA), preferred.
• Experience with NetSuite, preferred.

About this opportunity:

At Freenome, we are seeking a motivated Lab Technician to help grow the Freenome Scientific Operations team. The ideal candidate is eager to learn and able to work with urgency in an ever changing environment. This person is responsible for all things related to R&D support - reagents, equipment, consumables, study support.  You are passionate about fighting cancer, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

The role reports to the Supervisor, R&D Labs. This role will be an Onsite role.

What you’ll do:

• Collaborate with the Research, Development, Automation, Facilities and Supply Chain teams to ensure consistent laboratory support.
• Assist Research Associates and Scientists in preparing and aliquoting reagents.
• Perform routine maintenance on a variety of laboratory equipment.
• Assist with troubleshooting R&D lab equipment issues using established SOPs and WI’s.
• Operate automated liquid handling platforms to execute automated procedures.
• Assist with monitoring cold storage temperatures and respond to temperature excursion events.
• Assist with organizing and maintaining R&D reagent and sample inventory documentation.
• Act as a role model by demonstrating adherence to all proper safety protocols.
• Perform Accessioning and processing of patient samples.
• Support Biosample Management by  picking and pulling samples.
• Contribute to Study Execution by performing Genomics workflows.
  

Must haves:

• Bachelor's Degree with 1-2 years of related experience.
• Strong communication skills and the ability to collaborate across disciplines.
• Experience in writing or updating documentation such as WI’s, SOPs and maintaining a detailed Lab notebook.
• Ability to follow SOPs and troubleshoot effectively.
• Strong understanding of current molecular biology techniques and DNA sequencing.
• Attention to detail and documentation practices within a repetitive work function.
  

Nice to haves:

• Valuable supplementary skills include:
  • Experience handling and preparing blood and tissue samples.
  • Proficiency with automated liquid handling platforms and software.
  • Experience setting up Illumina sequencers.
  • Experience maintaining laboratory equipment.
  • Experience writing or updating documentation such as work instructions and SOPs.
  • Experience working in BSL-2 laboratories and familiarity with 5S organizational practices.
    

Benefits and additional information:

The US target range of our hourly rate for new hires is $30.60 - $39.12. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

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